AccessGUDID - DEVICE: NA (07613327062885)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0502880211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0502-880-211
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327062885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Rigid Optical Grasping Forceps

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17633	Urethrotome	A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope and accessories, flexible/rigid
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
KQT	EVACUATOR, GASTRO-UROLOGY
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d91fa38-cd57-413f-bd0f-739502234e66
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)624-4422
Email: xx@xx.xx

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